UN/SCETDG/42/INF.60
Committee of Experts on the Transport of Dangerous Goods
and on the Globally Harmonized System of Classification
and Labelling of Chemicals
Sub-Committee of Experts on the Transport of Dangerous Goods
6 December 2012
Forty-second session
Geneva, 3 – 11 December 2012
Item 2 (d) of the provisional agenda
Recommendations made by the Sub-Committee on its thirty-ninth,
fortieth and forty-first sessions and pending issues:
miscellaneous proposals for amendments to the Model Regulations
on the Transport of Dangerous Goods
Used Medical Devices
Transmitted by the Council on Safe Transportation of Hazardous
Articles (COSTHA)
Proposals
1. Given the concerns voiced by ICAO and the need for additional clarity, COSTHA
believes several proposals are warranted.
Proposal 1
2. Add the following definitions to 2.6.3.1:
Used health care device or equipment means a medical, diagnostic, or research
device or piece of equipment, or a personal care product used by consumers, medical
professionals, or pharmaceutical providers. A health care product is “used” when it
has been removed from its original packaging. It can be contaminated with
potentially infectious body fluids or materials, and is not decontaminated or
disinfected to remove or mitigate the infectious hazard prior to transport. Health care
devices or equipment contaminated with or suspected of contamination with a
Category A infectious substance shall not be transported as a used health care device
or equipment.
Contaminated sharps means any contaminated object that can penetrate the skin
including, but not limited to, needles, scalpels, broken glass, broken capillary tubes,
and exposed ends of dental wires.
Proposal 2
3. Modify the existing 2.6.3.2.3.7 to address equipment surface-contaminated with a
potentially infectious pathogen.
2.6.3.2.3.7
Except for:


medical waste (UN3291),
medical devices or equipment contaminated with or containing infectious substances in
Category A (UN2814 or UN2900), or
UN/SCETDG/42/INF.60

medical devices or equipment contaminated with or containing other dangerous goods
that meet the definition of another hazard class.
Used medical devices or equipment potentially surface-contaminated with infectious
pathogens and contaminated sharps which are being transported for disinfection,
cleaning, sterilization, repair or equipment evaluation are not subject to these Regulations
provided:
(a) Used mMedical devices or equipment potentially surface-contaminated
with or containing infectious substances which are being transported for
disinfection, cleaning, sterilization, repair, or equipment evaluation are not
subject to the provisions of these Regulations if Each medical device,
equipment and contaminated sharp is packed in packagings designed and
constructed in such a way that, under normal conditions of transport, they
cannot break, be punctured or leakrelease their contents. Packagings shall
be designed to meet the construction requirements listed in 6.1.4 or 6.6.45.
(b) These packagings shall meet the general packing requirements of 4.1.1.1
and 4.1.1.2 and be capable of retaining the medical devices, and equipment,
and sharps when dropped from a height of 1.2 m. [For air transport,
additional requirements may apply.]
(c) The packagings shall be marked “USED MEDICAL DEVICE” or “USED
MEDICAL EQUIPMENT”. When using overpacks, they shall be marked
in the same way, except when inscription remains visible.
NOTE: Medical equipment which has been drained of free liquid is deemed to meet the
requirements of this paragraph and is not subject to these Regulations.
Proposal 3
4. Add a new sub-paragraph, 2.6.3.2.3.8 for Used Medical Devices or Equipment
containing free liquid potentially contaminated with infectious pathogens:
2.6.3.2.3.8
Except for:




medical waste (UN3291),
medical devices or equipment contaminated with or containing infectious substances in
Category A (UN2814 or UN2900),
medical devices or equipment known to be contaminated with Category B (UN3373), or
medical devices or equipment contaminated with or containing other dangerous goods
that meet the definition of another hazard class.
Used Medical Devices or Equipment containing free liquid potentially contaminated with
infectious pathogens are not subject to these regulations provided:
(a) Each used health care device or equipment is drained of free liquid to the extent practicable and
shall be sealed to prevent leakage. The sealed device or equipment must be packed in a leakproof
inner packaging. The packaging must be designed and constructed in such a way that, under
normal conditions of transport, the inner packaging cannot break, be punctured, or leak their
contents. Sharps or other protrusions which may puncture the inner packaging must be protected
before packing in inner packagings. Absorbent material shall be placed between the sealed device
or equipment and the inner packaging. The absorbent material shall be in quantity sufficient to
absorb the entire contents of the sealed device.
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UN/SCETDG/42/INF.60
(b) Inner packagings shall be packed in rigid outer packagings meeting the design and construction
criteria of 6.1.4 and 6.6.4. Packages must be packed in conformance with the general packing
provision of 4.1.1.1, 4.1.1.2, and 4.1.1.5.
(c) Each outer packaging must contain a list of the devices or equipment and any potentially
infectious pathogens contained within. In addition, the package shall bear the marking “USED
MEDICAL DEVICE, USE APPROPRIATE PRECAUTIONS” or “USED MEDICAL
EQUIPMENT, USE APPROPRIATE PRECAUTIONS” on an internal surface in such a manner
that a warning of a potentially infectious substance is visible on of opening the package.
(d) Each person who offers a used health care device or equipment under the provisions of this
paragraph must receive adequate instruction on these Regulations commensurate with their
responsibilities.
(e) Used health care products intended for disposal as waste are not permitted to be transported under
this paragraph.
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UN/SCETDG/42/INF.60
Annex
Infectious Substance Flowmap
Q1.
Is the material and environmental sample (including food or water) which is not considered to
pose a significant risk? (2.6.3.2.3.4)
Yes
Go to Q6
No
Go to Q2
Q2.
Does the material meet the classification of CAT A Infectious Substances?
Yes
Ship as UN2814 or UN2900
No
Go to Q3
Q3.
Does the material contain or potentially contain CAT B Infectious Substances?
Yes
Go to Q4
No
Go to Q6
Q4.
Are the materials dried blood spots, faecal occult blood screening tests, blood or blood components
which have been collected for the purpose of transfusion or for the preparation of blood products to be
used for transfusion or transplantation or any tissues or organs intended for use in transplantation?
(2.6.3.2.3.5)
Yes
Go to Q6
No
Go to Q5
Q5
Does the material contain pathogens which could cause disease in humans or animals?
(2.6.3.2.3.1)
Yes
Go to Q7
No
Go to Q6
Q6.
Does the material meet the classification of any other hazard class?
Yes
Classed as another hazard class
No
Not Subject to these Regulations
Q7.
Does the material contain micro-organisms which are non-pathogenic? (2.6.3.2.3.2)
Yes
Go to Q6
No
Go to Q8
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UN/SCETDG/42/INF.60
Q8.
Is the material in a form that any present pathogens have been neutralized or inactivated such
that they no longer pose a health risk? (2.6.3.2.3.3)
NOTE: Medical equipment which has been drained of free liquid and meets the requirements of this
paragraph is not subject to these Regulations.
Yes
Go to Q6
No
Go to Q9
Q9.
Are the material human or animal specimens for which there is minimal likelihood that
pathogens are present and packed in accordance with 2.6.3.2.3.6?
Yes
Handled as Exempt Human Specimens or Exempt Animal Specimens (2.6.3.2.3.6)
No
Go to Q10
Q10.
Is the material contained on or within a medical device or equipment? (2.6.3.2.3.7)
Yes
Go to Q11
No
Ship as UN3373
Q11.
Are the materials medical waste? (2.6.3.2.3.7(a))
Yes
Ship as UN3191
No
Go to Q12
Q12. Is the medical device or equipment contaminated with or contain dangerous goods that meet the
definition of another hazard class? (2.6.3.2.3.7(c))
Yes
Go to Q6
No
Go to Q13
Q13.
Is the medical device or equipment packed in accordance with 2.6.3.2.3.7?
Yes
Ship as Used Medical Equipment (2.6.3.2.3.7)
No
Ship as UN3373
Proposed changes to Flowmap:
Q10.
Is the material contained on the surface of a medical device, equipment, or sharp? (2.6.3.2.3.7)
Yes
Go to Q11
No
Go to Q14
Q11.
Are the materials medical waste? (2.6.3.2.3.7(a))
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UN/SCETDG/42/INF.60
Yes
Ship as UN3191
No
Go to Q12
Q12. Is the medical device or equipment contaminated with or contain dangerous goods that meet the
definition of another hazard class? (2.6.3.2.3.7(c))
Yes
Go to Q6
No
Go to Q13
Q13.
Is the medical device or equipment packed in accordance with 2.6.3.2.3.7?
Yes
Ship as surface contaminated Used Medical Equipment (2.6.3.2.3.7)
No
Ship as UN3373
Q14.
Is the material a free liquid contained within a medical device or equipment?
Yes
Go to Q15
No
Ship as UN3373
Q15.
Are the materials medical waste? (2.6.3.2.3.8(a))
Yes
Ship as UN3191
No
Go to Q16
Q16. Is the medical device or equipment contaminated with or contain dangerous goods that meet the
definition of another hazard class? (2.6.3.2.3.8(c))
Yes
Go to Q6
No
Go to Q17
Q17.
Is the medical device or equipment packed in accordance with 2.6.3.2.3.8?
Yes
Ship as Used Medical Equipment containing free liquid (2.6.3.2.3.8)
No
Ship as UN3373
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